Endoscopic Myotomy of the Pylorus to Improve Emptying and Symptoms Trial

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 23, 2022

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Gastroparesis
Interventions
PROCEDURE

Endoscopic per-oral pyloromyotomy (POP)

Per-oral pyloromyotomy (POP), alternatively knows as gastric per-oral endoscopic myotomy (G-POEM), accomplishes longitudinal division of the pylorus using an endoscope. This procedure involves utilizing endoscopic electrosurgical knife to make an incision in the gastric mucosa and develop a submucosal tunnel to visualize the pyloric ring. The pyloric ring is divided longitudinally, and the mucosotomy incision is sealed with endoscopic clips.

PROCEDURE

Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption

While under general anesthesia, a standard gastroscope is introduced and a diagnostic upper endoscopy is performed. The operator talks through the procedure steps as if completing POP. The gastroscope is withdrawn and the patient is extubated.

Trial Locations (1)

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Matthew Allemang

OTHER